Interim medical director for MAA submission

Challenge: On behalf of a European pharmaceutical company, one of Alacrita’s professionals acted as medical director for the registration of a new agent in a neuroendocrine indication in territories...
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Developing vaccine products

Challenge The UK HIV Vaccines Consortium needed expert advice. The consortium was supporting and coordinating the development of several new HIV vaccines in academia. They needed guidance about which...
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Applying to Early Access to Medicines (EAMS) at the MHRA

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...
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EU value proposition and market access plan for orphan disease drug

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...
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US market access plan for antibody launch

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...
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Gap analysis & pre-IND meeting preparation for preclinical compound

Challenge: Our client planning to develop and commercialize a preclinical compound for metabolic disorders. The product had a wide therapeutic potential for disorders associated with disruption of...
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Due diligence on the developability & investability of a cancer vaccine

Challenge: A newly-formed US biotech company has acquired the intellectual property and assets of a legacy cancer vaccine company that had ceased trading several years ago following disappointing...
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Antiviral gap analysis for partnering and/or progression to IND

Challenge: A prominent researcher at an academic research institution had developed a class of small molecule compounds with in vitro antiviral activity against a family of RNA viruses. The...
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Regulatory strategy and preparation for pre-IND meeting with the FDA

Challenge: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in...
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Validating two potential hormone replacement therapy products with KOLs

Challenge: A clinical-stage company developing novel transdermal patch technology asked us to validate two potential hormone replacement therapy products with KOLs. The main focus was to evaluate the...
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Oligo technology applications mapping

Challenge: A startup with a novel technology for enzymatic synthesis of dsDNA approached Alacrita to assess potential opportunities for the technology in the biopharma space. Hitherto the company had...
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Liquid nanoparticle technology analysis & competitive landscape

Challenge: A privately held biotech company using AI/machine learning/Big Data to develop novel liquid nanoparticles (LNPs) and LNP formulations for particular payloads instead of using a traditional...
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